Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
ConditionDiabetic Ketoacidosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute
About this trial
The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids
Blood glucose level > 14mmol/L
pH < 7.25
Serum bicarbonate <15 mmol/L
Disqualifiers
Age less than 18 years
Patients who have received more than 2000ml of non study fluid prior to study enrolment
Serum Na > 155 or <120 mmol/L
Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148
Trial design
Design model
Crossover
Treatments tested in this trial
Plasma-Lyte 148
DrugPlasma-Lyte® 148 intravenous fluid for resuscitation in patients with keto-acidosis
0.9% sodium chloride
Drug0.9% sodium chloride intravenous fluid for resuscitation in patients with keto-acidosis
Treatment groups
680 Participants
are divided into 2 treatment groupsGroup A: Plasma-Lyte® 148Active comparator 1 intervention
Group B: 0.9% sodium chlorideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hospital free days (HFD) up to day-28 after study enrolment
Number of hospital free days from time of hospital discharge
Time frame
from time of enrolment to 28 daysSecondary outcomes
1
ICU free days up to 28 days after study enrolment
Number of ICU free days from time of ICU discharge
Time frame
28 days after enrolment2
ICU and hospital readmissions up to 28 days after study enrolment
Number of days free from ICU and hospital from time of hospital discharge
Time frame
28 days after enrolment3
Acute kidney injury assessed by comparing serum creatinine using Kidney Disease: Improving Global Outcomes (KDIGO) criteria
injury assessed by comparing change in serum creatinine using Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame
28 days after enrolment4
Episodes of post-study enrolment decrease in Glasgow Coma Scale (GCS) by more than 2 in the first 24 hours
decrease in Glasgow Coma Score by more than 2 points
Time frame
first 24 hours from enrolmentOther outcomes
1
Cost-effectiveness
Calculation of the incremental cost-effectiveness ratios
Time frame
from time of enrolment to day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov